MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PERFORMA®; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	7742-20M65SH/C
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
On (b)(6) 2025 a catheter burst during a procedure.This product will not be returned and no patient details or adverse event was reported.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: PERFORMA®
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; calle, sor juana inés de la cr; tijuana, b.c. 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; calle, sor juana inés de la cr; tijuana, b.c. 22630 ; MX 22630
• Manufacturer Contact: adrian cole ; 1600 w merit parkway; south jordan
• MDR Report Key: 22676618
• Report Number: 1721504-2025-00197
• Device Sequence Number: 9000383
• Product Code: DQO
• UDI-Device Identifier: 00884450843017
• UDI-Public: 00884450843017
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K000659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 7742-20M65SH/C
• Device Lot Number: I2988688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown